The Lived Experience of Managing HIV and Chronic Pain: Qualitative Interviews with Patients and Healthcare Providers.

People living with HIV (PLWH) experience higher rates of comorbid chronic pain conditions compared to the general population. Managing HIV and chronic pain, two stigmatized health conditions, can exacerbate physical and psychological suffering. The current qualitative study was designed to increase our understanding of the experience of living with HIV and chronic pain. Twenty participants were recruited from a hospital-based immunology center to participate in individual in-depth qualitative interviews. The interviews focused on the experience of living with (or managing) chronic pain for PLWH. All interviews were audio recorded, transcribed and double-coded. Several themes emerged from our applied thematic analysis of the transcripts. The primary theme was that pain remained poorly managed among PLWH. Patients engaged in a variety of pain management strategies and described benefits from both traditional pain management interventions (e.g., pharmacology, physical therapy) as well as non-traditional approaches (e.g., medical marijuana, cannabidiol products, and spirituality). Other themes that emerged included barriers related to health insurance and the need to validate the patient pain experience. PLWH and chronic pain described compounding effects of managing two chronic health conditions, including perceived immune system over-activation, heightened awareness of illness, and negative mindset. More research is needed to improve care for those managing these often co-occurring health conditions.

"I'd feel like someone was watchin' me watching for a good reason": perceptions of data privacy, access, and sharing in the context of real-time PrEP adherence monitoring among HIV-negative MSM with substance use.

Once-daily oral tenofovir/emtricitabine is highly effective as pre-exposure prophylaxis (PrEP) against HIV but is dependent on adherence, which may be challenging for men who have sex with men (MSM) and use substances. Digital pill systems (DPS) permit the direct, real-time measurement of adherence, though user perceptions of data privacy in this context are unknown. Thirty prospective DPS users - HIV-negative MSM with non-alcohol substance use - completed in-depth qualitative interviews exploring preferences around privacy, access, and sharing of DPS adherence data. Participants discussed some concerns about the impact of DPS use on personal privacy, and emphasized the need for robust data protections in the technology. Participants were interested in having on-demand access to their adherence data, and were most willing to share data with primary care providers and long-term relationship partners. Future investigations exploring bioethical frameworks around DPS use are warranted, and user preferences should inform best practices for protecting DPS data.

Real-World User Experiences with a Digital Pill System to Measure PrEP Adherence: Perspectives from MSM with Substance Use.

Once-daily oral pre-exposure prophylaxis (PrEP) is highly effective for preventing HIV transmission, but adherence can be challenging for men who have sex with men (MSM) who use substances. A novel method for directly measuring ingestion events is a digital pill system (DPS), which comprises an ingestible radiofrequency emitter that signals a wearable Reader device upon PrEP ingestion, relaying ingestion data to a wearable Reader device and then to a smartphone application. Qualitative interviews were conducted with 15 MSM with non-alcohol substance use following an open-label pilot demonstration trial involving use of the DPS to measure PrEP adherence for 90 days. The purpose of this qualitative investigation was to understand overall user experiences and potential barriers and facilitators to using the DPS to measure PrEP adherence among MSM. The DPS was largely perceived as acceptable, novel, and valuable, with most participants reporting that the system was easily integrated into their daily routines. Technological and design factors, especially related to the wearable Reader, impacted participants' interest in using the technology long-term; several suggested improvements were discussed.Trial Registration ClinicalTrials.gov: NCT03842436.

Using Social Media for Clinical Research: Recommendations and Examples From the Brown-Lifespan Center for Digital Health.

Social media integration into research has increased, and 92% of American social media participants state they would share their data with researchers. Yet, the potential of these data to transform health outcomes has not been fully realized, and the way clinical research is performed has been held back. The use of these technologies in research is dependent on the investigators' awareness of their potential and their ability to innovate within regulatory and institutional guidelines. The Brown-Lifespan Center for Digital Health has launched an initiative to address these challenges and provide a helpful framework to expand social media use in clinical research.

Design and Delivery of Real-Time Adherence Data to Men Who Have Sex with Men Using Antiretroviral Pre-exposure Prophylaxis via an Ingestible Electronic Sensor.

Once daily tenofovir/emtricitabine when used for pre-exposure prophylaxis (PrEP) is effective in preventing HIV acquisition but requires consistent medication adherence. The use of ingestible technologies to monitor PrEP adherence can assist in understanding the impact of behavioral interventions. Digital pill systems (DPS) utilize an ingestible radiofrequency emitter integrated onto a gelatin capsule, which permits direct, real-time measurement of medication adherence. DPS monitoring may lead to discovery of nascent episodes of PrEP nonadherence and allow delivery of interventions that prevent the onset of sustained nonadherence. Yet, the acceptance and potential use of DPS in high-risk men who have sex with men (MSM; i.e., those who engage in condomless sex and use substances) is unknown. In this investigation, we conducted individual, semi-structured qualitative interviews with 30 MSM with self-reported non-alcohol substance use to understand their responses to the DPS, willingness and perceived barriers to its use, and their perceptions of its potential utility. We also sought to describe how MSM would potentially interact with a messaging system integrated into the DPS. We identified major themes around improved confidence of PrEP adherence patterns, safety of ingestible radiofrequency sensors, and design optimization of the DPS. They also expressed willingness to interact with messaging contingent on DPS recorded ingestion patterns. These data demonstrate that MSM who use substances find the DPS to be an acceptable method to measure and record PrEP adherence.

Telephone-delivered behavioral health interventions for people living with HIV: patients' perspectives from a qualitative study.

People living with HIV (PLWH) often experience mental health concerns as well as difficulties with medication adherence; they also report barriers to receipt of health services. Telephone-delivered interventions can overcome some of these barriers. To obtain patients' perspectives on telephone-delivered behavioral health services, we conducted a qualitative study with patients who participated in one of two telephone-delivered interventions (mindfulness training, health coaching) in a research trial. Patients (N = 42; M age = 46 years, 50% female, 26% Black) participated in semi-structured qualitative interviews after completing the study. They identified several advantages (e.g., being able to schedule sessions more flexibly compared to in-person appointments, ease of developing rapport with interventionists) as well as occasional challenges of phone delivery (e.g., network connectivity). Overall, PLWH view telephone-delivery as a convenient and flexible method to engage in behavioral health interventions.

Long-Term Stability of the Electronic Sensor Component of a Digital Pill System in Real-World Storage Settings.

Background: Digital pill systems comprise an ingestible sensor integrated into a gelatin capsule that overencapsulates medication allowing real-time measures of medication ingestion. These systems may improve the manner in which medication adherence can be assessed and supported. Objective: In this investigation, we tested the durability of the ingestible sensor as part of a clinical trial to measure the feasibility and acceptability of the system to measure adherence to once daily tenofovir disoproxil fumarate/emtricitabine (NCT03842436). Methods: Digital pills not dispensed during the study were stored in a pharmacy. Seventeen sensors were selected from digital pills stored for at least 12 months and activated in a simulated gastric environment. A radiofrequency spectrum analyzer and the reader device used in the clinical trial to capture ingestion events were used to measure activation of emitters. A passing evaluation was defined as an energized emitter within 30 minutes of immersion, ability to broadcast a signal for 10 minutes, and successful acquisition by the reader. Results: All ingestible sensors passed the stability test. Mean activation time in simulated gastric fluid was 3.33 minutes (SD = 1.47); emitters remained active for a mean of 47.72 minutes (SD = 1.78). These parameters matched guidelines defined in the ID-Cap system requirements for use in patients. Conclusions: Ingestible sensor components of the ID-Cap system were therefore stable after long-term storage.

Telephone-Delivered Mindfulness Training to Promote Medication Adherence and Reduce Sexual Risk Behavior Among Persons Living with HIV: An Exploratory Clinical Trial.

This study explored whether telephone-delivered mindfulness training (MT) to promote medication adherence and reduce sexual risk behavior was feasible for and acceptable to people living with HIV. Participants (N = 42; 50% female; M age = 47.5 years) were randomized to MT or health coaching (HC). Pre- and post-intervention, and at 3-month follow-up, we assessed adherence to ART, sexual risk behavior, and hypothesized mediators; we also conducted individual interviews to obtain qualitative data. Results showed that 55% of patients assigned to MT completed ≥ 50% of the training calls compared with 86% of HC patients (p < .05). Most patients reported satisfaction with their intervention (MT = 88%, HC = 87%). Patients in MT and HC reported improvements in medication adherence, mindfulness, and sexual risk reduction as well as reductions in anxiety, depressive symptoms, perceived stress, and impulsivity over time; however, no between-groups differences were observed.

Yoga as a Complementary Therapy for Smoking Cessation: Results From BreathEasy, a Randomized Clinical Trial.

INTRODUCTION: There is evidence that Yoga may be helpful as an aid for smoking cessation. Yoga has been shown to reduce stress and negative mood and may aid weight control, all of which have proven to be barriers to quitting smoking. This study is the first rigorous, randomized clinical trial of Yoga as a complementary therapy for smokers attempting to quit. METHODS: Adult smokers (N = 227; 55.5% women) were randomized to an 8-week program of cognitive-behavioral smoking cessation and either twice-weekly Iyengar Yoga or general Wellness classes (control). Assessments included cotinine-verified 7-day point prevalence abstinence at week 8, 3-month, and 6-month follow-ups. RESULTS: At baseline, participants' mean age was 46.2 (SD = 12.0) years and smoking rate was 17.3 (SD = 7.6) cigarettes/day. Longitudinally adjusted models of abstinence outcomes demonstrated significant group effects favoring Yoga. Yoga participants had 37% greater odds of achieving abstinence than Wellness participants at the end of treatment (EOT). Lower baseline smoking rates (≤10 cigarettes/day) were also associated with higher likelihood of quitting if given Yoga versus Wellness (OR = 2.43, 95% CI = 1.09% to 6.30%) classes at EOT. A significant dose effect was observed for Yoga (OR = 1.12, 95% CI = 1.09% to 1.26%), but not Wellness, such that each Yoga class attended increased quitting odds at EOT by 12%. Latent Class Modeling revealed a 4-class model of distinct quitting patterns among participants. CONCLUSIONS: Yoga appears to increase the odds of successful smoking abstinence, particularly among light smokers. Additional work is needed to identify predictors of quitting patterns and inform adjustments to therapy needed to achieve cessation and prevent relapse. IMPLICATIONS: This study adds to our knowledge of the types of physical activity that aid smoking cessation. Yoga increases the odds of successful smoking abstinence, and does so in a dose-response manner. This study also revealed four distinct patterns of smoking behavior among participants relevant to quitting smoking. Additional work is needed to determine whether variables that are predictive of these quitting patterns can be identified, which might suggest modifications to therapy for those who are unable to quit.

Marijuana as a Substitute for Prescription Medications: A Qualitative Study.

Background: Over the past few decades in the United States, marijuana for medical purposes has become increasingly prevalent. Initial qualitative and epidemiological research suggests that marijuana may be a promising substitute for traditional pharmacotherapies. Objectives: This qualitative study examined perceptions relating to (1) using medical marijuana in comparison to other prescription medications and (2) user perception of policy issues that limit adoption of medical marijuana use. Methods: Qualitative interviews were conducted with Rhode Island medical marijuana card holders (N = 25). The interviews followed a semi-structured agenda designed to collect information from participants about their reasons for, and perceptions of, medical marijuana use. All interviews were audio recorded, transcribed verbatim, and de-identified. Qualitative codes were developed from the agenda and emergent topics raised by the participants. Results: Three themes emerged related to medical marijuana use, including (1) comparison of medical marijuana to other medications (i.e., better and/or fewer side effects than prescription medications, improves quality of life), (2) substitution of marijuana for other medications (i.e., in addition to or instead of), and (3) how perception of medical marijuana policy impacts use (i.e., stigma, travel, cost, and lack of instruction regarding use). Conclusions: Several factors prevent pervasive medical marijuana use, including stigma, cost, and the inability for healthcare providers to relay instructions regarding dosing, strain, and method of use. Findings suggest that medical patients consider marijuana to be a viable alternative for opioids and other prescription medications, though certain policy barriers inhibit widespread implementation of marijuana as a treatment option.

Safety and pharmacokinetics of single, dual, and triple antiretroviral drug formulations delivered by pod-intravaginal rings designed for HIV-1 prevention: A Phase I trial.

BACKGROUND: Intravaginal rings (IVRs) for HIV pre-exposure prophylaxis (PrEP) theoretically overcome some adherence concerns associated with frequent dosing that can occur with oral or vaginal film/gel regimens. An innovative pod-IVR, composed of an elastomer scaffold that can hold up to 10 polymer-coated drug cores (or "pods"), is distinct from other IVR designs as drug release from each pod can be controlled independently. A pod-IVR has been developed for the delivery of tenofovir (TFV) disoproxil fumarate (TDF) in combination with emtricitabine (FTC), as daily oral TDF-FTC is the only Food and Drug Administration (FDA)-approved regimen for HIV PrEP. A triple combination IVR building on this platform and delivering TDF-FTC along with the antiretroviral (ARV) agent maraviroc (MVC) also is under development. METHODOLOGY AND FINDINGS: This pilot Phase I trial conducted between June 23, 2015, and July 15, 2016, evaluated the safety, pharmacokinetics (PKs), and acceptability of pod-IVRs delivering 3 different ARV regimens: 1) TDF only, 2) TDF-FTC, and 3) TDF-FTC-MVC over 7 d. The crossover, open-label portion of the trial (N = 6) consisted of 7 d of continuous TDF pod-IVR use, a wash-out phase, and 7 d of continuous TDF-FTC pod-IVR use. After a 3-mo pause to evaluate safety and PK of the TDF and TDF-FTC pod-IVRs, TDF-FTC-MVC pod-IVRs (N = 6) were evaluated over 7 d of continuous use. Safety was assessed by adverse events (AEs), colposcopy, and culture-independent analysis of the vaginal microbiome (VMB). Drug and drug metabolite concentrations in plasma, cervicovaginal fluids (CVFs), cervicovaginal lavages (CVLs), and vaginal tissue (VT) biopsies were determined via liquid chromatographic-tandem mass spectrometry (LC-MS/MS). Perceptibility and acceptability were assessed by surveys and interviews. Median participant age was as follows: TDF/TDF-FTC group, 26 y (range 24-35 y), 2 White, 2 Hispanic, and 2 African American; TDF-FTC-MVC group, 24.5 y (range 21-41 y), 3 White, 1 Hispanic, and 2 African American. Reported acceptability was high for all 3 products, and pod-IVR use was confirmed by residual drug levels in used IVRs. There were no serious adverse events (SAEs) during the study. There were 26 AEs reported during TDF/TDF-FTC IVR use (itching, discharge, discomfort), with no differences between TDF alone or in combination with FTC observed. In the TDF-FTC-MVC IVR group, there were 12 AEs (itching, discharge, discomfort) during IVR use regardless of attribution to study product. No epithelial disruption/thinning was seen by colposcopy, and no systematic VMB shifts were observed. Median (IQR) tenofovir diphosphate (TFV-DP) tissue concentrations of 303 (277-938) fmol/10(6) cells (TDF), 289 (110-603) fmol/10(6) cells (TDF-FTC), and 302 (177.1-823.8) fmol/10(6) cells (TDF-FTC-MVC) were sustained for 7 d, exceeding theoretical target concentrations for vaginal HIV prevention. The study's main limitations include the small sample size, short duration (7 d versus 28 d), and the lack of FTC triphosphate measurements in VT biopsies. CONCLUSIONS: An innovative pod-IVR delivery device with 3 different formulations delivering different regimens of ARV drugs vaginally appeared to be safe and acceptable and provided drug concentrations in CVFs and tissues exceeding concentrations achieved by highly protective oral dosing, suggesting that efficacy for vaginal HIV PrEP is achievable. These results show that an alternate, more adherence-independent, longer-acting prevention device based on the only FDA-approved PrEP combination regimen can be advanced to safety and efficacy testing. TRIAL REGISTRATION: ClinicalTrials.gov NCT02431273.

Mediators of a physical activity intervention among women with a family history of breast cancer.

The current study examined mediators of an efficacious physical activity intervention. Women with a mean age of 42.6 (range 23-61) years and a family history of breast cancer were randomized to either an Internet-based physical activity intervention (n = 28) or an active control condition (n = 27) for three months. Data were collected between November 2010 and August 2011. Hypothesized mediators were examined using a product of coefficients model with bootstrapped standard errors. Significant mediation was observed for both self-efficacy and behavioral processes. Specifically, the regression coefficients of the indirect effects ("ab path": unstandardized effect of the intervention on physical activity that occurred through the mediator) were ab = 38.58 (95% confidence interval [CI]: 8.66-92.76) for self-efficacy, and ab = 42.02 (95% CI: 6.76-104.84) for behavioral processes. Other factors examined in this study, including cognitive processes, decisional balance, and perceived risk of breast cancer, were not statistically significant mediators. Findings suggest that self-efficacy and behavioral processes may be key constructs to use in targeting future physical activity interventions among women with a family history of breast cancer.

Women's reproductive decision making and abortion experiences in Cape Town, South Africa: A qualitative study.

Unintended pregnancy is a significant public health issue in South Africa. Despite free services including contraception, women face structural and institutional barriers to accessing care. This qualitative study comprised interviews with 16 women aged 18 to 40 years and receiving post-abortion services at a public clinic in Cape Town. Data analysis revealed three main themes: personal journeys in seeking abortion, contraceptive experiences, and contrasting feelings of empowerment (in reproductive decision making) and disempowerment (in the health care system). Women perceived themselves as solely responsible for their reproductive health, but found it difficult to obtain adequate information or services.

Telephone-Delivered Mindfulness Training for People Living with HIV: A Qualitative 360° Inquiry.

For people living with HIV and AIDS (PLWHA), life stress often undermines quality of life and interferes with medical care. Mindfulness training (MT) may help PLWHA to manage stress. Because standard MT protocols can be burdensome, we explored telephone delivery as a potentially more feasible approach. We used an innovative 360° qualitative inquiry to seek input regarding telephone-delivery of MT for PLWHA in advance of a planned intervention trial. We also sought input on a time- and attention-matched control. Twenty five HIV patients, providers and advocates, were recruited to five focus groups. Participants understood the construct of mindfulness and recognized its potential benefits for stress management and improving medication adherence. Patients preferred the term "mindfulness" to meditation. Telephone-delivery appealed to all patients but several challenges were raised. Topics for the control intervention included nutrition, sleep, and aging. The 360° approach allowed three groups (patients, providers, advocates) to influence intervention development.

Breast cancer relatives' physical activity intervention needs and preferences: qualitative results.

BACKGROUND: While many risk factors for breast cancer, such as family history, are not modifiable, some, however, can be modified. The study used formative qualitative research to learn about the physical activity intervention preferences and needs of first-degree female relatives (FDFRs) of breast cancer patients; that information was then used to develop a targeted physical activity intervention. METHODS: Twenty FDFRs first completed a 12-week physical activity intervention and then attended two sequential focus groups (7 groups total). In the first set of focus groups participants provided feedback on the intervention. In the follow-up focus groups, proposed changes based on collected responses from the first groups were presented and participants provided feedback to further refine the intervention. RESULTS: Overall, we found strong interest for an intervention using breast cancer-related health concerns to promote positive behavior change. A theme underlying all of the feedback was the desire for a personalized intervention that was directly relevant to their lives. Participants wanted this personalization achieved through individually tailored content and incorporation of stories from other FDFRs. In order to successfully use concerns about breast cancer to motivate behavior change, participants also wanted a discussion about their individual risk factors for breast cancer including, but not limited to, lack of physical activity. CONCLUSIONS: This study demonstrates women's interest in receiving personalized information and highlights specific ways to individualize an intervention that increases motivation and engagement. Using a sequential qualitative approach was effective for formative intervention development. TRIAL REGISTRATION NUMBER: NCT03115658 (Retrospectively registered 4/13/17).

Digital Pills to Measure Opioid Ingestion Patterns in Emergency Department Patients With Acute Fracture Pain: A Pilot Study.

BACKGROUND: Nonadherence to prescribed regimens for opioid analgesic agents contributes to increasing opioid abuse and overdose death. Opioids are frequently prescribed on an as-needed basis, placing the responsibility to determine opioid dose and frequency with the patient. There is wide variability in physician prescribing patterns because of the lack of data describing how patients actually use as-needed opioid analgesics. Digital pill systems have a radiofrequency emitter that directly measures medication ingestion events, and they provide an opportunity to discover the dose, timing, and duration of opioid therapy. OBJECTIVE: The purpose of this study was to determine the feasibility of a novel digital pill system to measure as-needed opioid ingestion patterns in patients discharged from the emergency department (ED) after an acute bony fracture. METHODS: We used a digital pill with individuals who presented to a teaching hospital ED with an acute extremity fracture. The digital pill consisted of a digital radiofrequency emitter within a standard gelatin capsule that encapsulated an oxycodone tablet. When ingested, the gastric chloride ion gradient activated the digital pill, transmitting a radiofrequency signal that was received by a hip-worn receiver, which then transmitted the ingestion data to a cloud-based server. After a brief, hands-on training session in the ED, study participants were discharged home and used the digital pill system to ingest oxycodone prescribed as needed for pain for one week. We conducted pill counts to verify digital pill data and open-ended interviews with participants at their follow-up appointment with orthopedics or at one week after enrollment in the study to determine the knowledge, attitudes, beliefs, and practices regarding digital pills. We analyzed open-ended interviews using applied thematic analysis. RESULTS: We recruited 10 study participants and recorded 96 ingestion events (87.3%, 96/110 accuracy). Study participants reported being able to operate all aspects of the digital pill system after their training. Two participants stopped using the digital pill, reporting they were in too much pain to focus on the novel technology. The digital pill system detected multiple simultaneous ingestion events by the digital pill system. Participants ingested a mean 8 (SD 5) digital pills during the study period and four participants continued on opioids at the end of the study period. After interacting with the digital pill system in the real world, participants found the system highly acceptable (80%, 8/10) and reported a willingness to continue to use a digital pill to improve medication adherence monitoring (90%, 9/10). CONCLUSIONS: The digital pill is a feasible method to measure real-time opioid ingestion patterns in individuals with acute pain and to develop real-time interventions if opioid abuse is detected. Deploying digital pills is possible through the ED with a short instructional course. Patients who used the digital pill accepted the technology.

PULSE-SMART: Pulse-Based Arrhythmia Discrimination Using a Novel Smartphone Application.

BACKGROUND: Atrial fibrillation (AF) is a common and dangerous rhythm abnormality. Smartphones are increasingly used for mobile health applications by older patients at risk for AF and may be useful for AF screening. OBJECTIVES: To test whether an enhanced smartphone app for AF detection can discriminate between sinus rhythm (SR), AF, premature atrial contractions (PACs), and premature ventricular contractions (PVCs). METHODS: We analyzed two hundred and nineteen 2-minute pulse recordings from 121 participants with AF (n = 98), PACs (n = 15), or PVCs (n = 15) using an iPhone 4S. We obtained pulsatile time series recordings in 91 participants after successful cardioversion to sinus rhythm from preexisting AF. The PULSE-SMART app conducted pulse analysis using 3 methods (Root Mean Square of Successive RR Differences; Shannon Entropy; Poincare plot). We examined the sensitivity, specificity, and predictive accuracy of the app for AF, PAC, and PVC discrimination from sinus rhythm using the 12-lead EKG or 3-lead telemetry as the gold standard. We also administered a brief usability questionnaire to a subgroup (n = 65) of app users. RESULTS: The smartphone-based app demonstrated excellent sensitivity (0.970), specificity (0.935), and accuracy (0.951) for real-time identification of an irregular pulse during AF. The app also showed good accuracy for PAC (0.955) and PVC discrimination (0.960). The vast majority of surveyed app users (83%) reported that it was "useful" and "not complex" to use. CONCLUSION: A smartphone app can accurately discriminate pulse recordings during AF from sinus rhythm, PACs, and PVCs.

Psychometric Properties and Validity of a Multi-dimensional Risk Perception Scale Developed in the Context of a Microbicide Acceptability Study.

Currently available risk perception scales tend to focus on risk behaviors and overall risk (vs partner-specific risk). While these types of assessments may be useful in clinical contexts, they may be inadequate for understanding the relationship between sexual risk and motivations to engage in safer sex or one's willingness to use prevention products during a specific sexual encounter. We present the psychometric evaluation and validation of a scale that includes both general and specific dimensions of sexual risk perception. A one-time, audio computer-assisted self-interview was administered to 531 women aged 18-55 years. Items assessing sexual risk perceptions, both in general and in regards to a specific partner, were examined in the context of a larger study of willingness to use HIV/STD prevention products and preferences for specific product characteristics. Exploratory and confirmatory factor analyses yielded two subscales: general perceived risk and partner-specific perceived risk. Validity analyses demonstrated that the two subscales were related to many sociodemographic and relationship factors. We suggest that this risk perception scale may be useful in research settings where the outcomes of interest are related to motivations to use HIV and STD prevention products and/or product acceptability. Further, we provide specific guidance on how this risk perception scale might be utilized to understand such motivations with one or more specific partners.

"Set it and forget it": women's perceptions and opinions of long-acting topical vaginal gels.

Women's initial understandings and anticipated acceptability of long-acting vaginal gels as potential anti-HIV microbicides was investigated by exploring the perceptibility variables associated with prototype formulations. Four focus groups with 29 women, aged 18-45, were conducted to consider gel prototypes with varied physicochemical and rheological properties. Participants responded favorably to the concept of long-acting vaginal gels as microbicides. Distinctions in understandings and stated needs regarding product dosing, characteristics, and effectiveness offer valuable insights into product design. Long-acting vaginal gels capable of protecting against HIV/STIs will be a viable option among potential users, with dosing frequency being an important factor in willingness to use.

User-identified gel characteristics: a qualitative exploration of perceived product efficacy of topical vaginal microbicides.

Research has demonstrated that certain vaginal gel products--microbicides containing antiretroviral drugs--may reduce HIV infection risk among women. But for vaginal gels to avert HIV and other sexually transmitted infections (STIs), at-risk women must be willing to use them as directed. These products must therefore be "acceptable" to women and an important component of acceptability is users' perception that the product will work to prevent infection. We sought to understand how women's perceptions of vaginal gel properties may shape their understanding of product efficacy for HIV and STI prevention. Sixteen women completed two in-depth qualitative interviews (k = 32) to identify the range and types of sensory perceptions they experienced when using two vaginal gels. We identified emergent themes and linkages between users' sensory perceptions and their beliefs about product efficacy. Users' predictions about product efficacy for preventing infection corresponded to measurable physical properties, including gel volume, location in the vagina, coating behavior, sensation of the gel in the vagina, leakage, and gel changes during coital acts. Although the women described similar sensory experiences (e.g., gel leaked from the vagina), they interpreted these experiences to have varying implications for product efficacy (e.g., leakage was predicted to increase or decrease efficacy). To improve microbicide acceptability, gel developers should investigate and deliberately incorporate properties that influence users' perceptions of efficacy. When a microbicide is approved for use, providers should educate users to anticipate and understand their sensory experiences; improving users' experience can maximize adherence and product effectiveness.